Food and Drug Administration

The U.S. Food and Drug Administration (FDA) is responsible for ensuring the safety of drugs and medical devices approved for the U.S., as well as regulating promotional messaging for these products. The Pew Prescription Project supports increased funding to enable the FDA to fully meet its public health mission. The Project also works to improve consumer safety through improvements in FDA oversight of manufacturing, approvals and marketing of drugs and medical devices.

• GAO Report: FDA medical devices should receive stringent pre-market approval
• The FDA's Oversight of Clinical Investigators' Financial Information: HHS OIG 2009
• Risk with No Benefit: the Marketing of Over-the-Counter Cough and Cold Medications to Children

• Testimony of Allan Coukell, Director of the Pew Prescription Project, on Protecting Consumers from Adulterated Drugs
• FDA memo to Health and Human Services transition team
• Comments to FDA concerning draft guidance on off-label journal reprints
• Comments to FDA concerning limitations and risks of direct-to-consumer advertising

• Safety of the Prescription Drug Supply